Main roads
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The US Food and Drug Administration has approved Lipfendra, the first pill to block a cholesterol-raising protein called PCSK9.
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The daily list price of the tablets is $315 per month, which is $500 to $600 less than the injectable versions.
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In two trials of 3,207 adults, bad cholesterol dropped from 56% to 59% after 24 weeks.
THURSDAY, July 16, 2026 (NewsDay News) — A new daily pill is giving people with stubbornly high cholesterol a cheaper, needle-free way to lower their levels.
The US Food and Drug Administration (FDA) acted today to approve it Lipphendra (enlicitide), is the first oral drug that blocks the protein PCSK9, which limits how much “bad” LDL cholesterol the body clears from the blood.
Injectable PCSK9 inhibitors have been on the market for years, but list prices run from $500 to $600 or more per month, and some patients don’t want the shot. New York Times.
A Merck spokeswoman said Lipphendra will list for $315 for a 30-day supply and should arrive in pharmacies within a few weeks. Julie Cunningham said The Times.
The FDA has approved the once-daily tablet for use with diet and exercise in adults high cholesterol and in those with heterozygous familial hypercholesterolemia (HeFH), the inherited form of the condition.
The FDA said two trials involving 3,207 adults already approved the highest statin doses they could tolerate.
In the first study that registered people who had atherosclerotic cardiovascular disease (ASCVD) or were at high risk for it, mean LDL was reduced by 56% from a baseline of 96 mg/dL after 24 weeks compared to placebo.
In the second study, limited to adults with hereditary HeFH, LDL was reduced by 59% from an average of 119 mg/dL.
ASCVD is when plaque builds up in the blood vessels leading to the heart, in which cholesterol plays a major role.
According to the FDA, the side effects of the drug were about the same as placebo in the first trial. In the HeFH trial, diarrhea and dizziness were more common with Lipphendra. Similar proportions of patients in both groups discontinued treatment due to side effects.
Injectable PCSK9 inhibitors are cut heart attack, the blows and cardiovascular mortality of 20% in high-risk patients, according to the data The Times. Merck is conducting a trial to see if Lipphendra does the same.
Cardiologists welcomed this confirmation.
“I’m excited” Dr. Christopher Cannonsaid a cardiologist at Brigham and Women’s Hospital in Boston The Times. He consults with several drug manufacturers, but not Merck.
“This will make a huge difference compared to the cost of injectable PCSK9 inhibitors,” he said Dr. David Marona preventive cardiologist at Stanford University in California.
Merck wants to lower cholesterol with the drug so that it feels as normal as taking a statin, and that primary care physicians, not just cardiologists, can prescribe it. Dr. Dean Leesaid the president of the Merck research laboratory The Times.
New instructions The American Heart Association and the American College of Cardiology urge people at average risk of heart attack or stroke to have an LDL below 70, and those at high risk, such as heart attack survivors, to be 55 or older.
More information
For more information, visit the US Centers for Disease Control and Prevention lowering cholesterol.
SOURCES: New York TimesJuly 16, 2026; US Food and Drug Administration, 16 July 2026
What does this mean for you?
If your cholesterol levels are still high despite taking statins, ask your doctor if this drug is worth trying.
